Progesterone for the Treatment of Traumatic Brain Injury - Full Text View

Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)

This study is currently recruiting participants.

Verified March 2010 by Emory University

First Received on January 14, 2009. Last Updated on July 14, 2011 History of Changes

Sponsor:	Emory University
Collaborators:	Henry Ford Hospital Medical College of Wisconsin New York Presbyterian Hospital Oregon Health and Science University Stanford University Temple University University of Arizona University of California University of Cincinnati University of Kentucky University of Maryland University of Minnesota - Clinical and Translational Science Institute University of Texas University of Pennsylvania Virginia Commonwealth University Wayne State University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00822900

Purpose

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.

Condition	Intervention	Phase
Traumatic Brain Injury	Drug: Progesterone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.

Resource links provided by NLM:

MedlinePlus related topics: Injuries Traumatic Brain Injury Wounds

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Progesterone will significantly increase the proportion of patients with a favorable outcome as determined by the Glasgow Outcome Scale-Extended (GOSE) score at 6 months post injury when compared to placebo. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examine the efficacy of IV progesterone vs. placebo for treating patients with moderate to severe TBI on additional 6 month outcomes: Mortality, DRS, cognitive, neurological and functional outcomes, and rates of AE's and SAE's. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment:	1140
Study Start Date:	March 2010
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Progesterone Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.	Drug: Progesterone Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.

Arms

Assigned Interventions

Experimental: Progesterone

Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.

Drug: Progesterone

Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate to severe brain injury (GCS 12-4)
Age 18 years or older
Blunt, closed head injury
Arrival < 4 hours from injury

Exclusion Criteria:

Non-Survivable injury
Bilateral dilated unresponsive pupils
Severe intoxication (ETOH > 250 mg %)
Spinal cord injury with neurological deficits
Inability to perform activities of daily living prior to injury
Cardiopulmonary arrest
Status epilepticus on arrival
SBP < 90 on arrival or for at least 5 minutes prior to enrollment
O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment
Prisoner or ward of state
Pregnant
Active breast or reproductive organ cancers
Known allergy to progesterone or intralipid components (egg yolk)
Known history of clotting disorder
Active thromboembolic event
Concern for inability to follow up at 6 months
Anyone listed in the Opt out registry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822900

Contacts

Contact: Harriet A Howlett-Smith, RN CCRC	404-778-1714	hhowlet@emory.edu
Contact: David W Wright, MD	404-616-6010	david.wright@emory.edu

Show 25 Study Locations

Sponsors and Collaborators

Emory University

Henry Ford Hospital

Medical College of Wisconsin

New York Presbyterian Hospital

Oregon Health and Science University

Stanford University

Temple University

University of Arizona

University of California

University of Cincinnati

University of Kentucky

University of Maryland

University of Minnesota - Clinical and Translational Science Institute

University of Texas

University of Pennsylvania

Virginia Commonwealth University

Wayne State University

More Information

No publications provided

Responsible Party:	David W. Wright, MD, Emory University
ClinicalTrials.gov Identifier:	NCT00822900 History of Changes
Other Study ID Numbers:	IRB00014409, 1RO1 NS062778-01
Study First Received:	January 14, 2009
Last Updated:	July 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Trauma
Brain Injury

Additional relevant MeSH terms:

Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012